Abstract:

Disclosed is a fluid collection device wherein multiple, individual
samples of fluid can be collected simultaneously. The device includes a
chamber and an adapter which substantially and simultaneously distributes
the blood to individual chambers with chamber specific additives. Also
included is a system for using the blood collection device, preferably
within a diagnostic testing laboratory.

Claims:

1. A system for accessing biological fluid for analytical testing,
comprising:a cartridge comprising an inlet port, and a plurality of
extraction ports, an internal chamber for each extraction port, wherein
the internal chambers are capable of establishing fluid communication
with each extraction port; andan analyzer for receiving the cartridge,
the analyzer further comprising at least one extraction probe for
extracting a biological fluid from each of the extraction ports.

2. The system of claim 1, wherein the analyzer performs at least two
different analytical tests on at least two of the internal chambers.

3. The system of claim 2, wherein the analytical tests are chosen from the
group consisting of coagulation, hematology, immunochemistry, and
clinical chemistry.

4. A method for aliquoting biological fluids comprising the steps
of:receiving a cartridge, the cartridge comprising multiple internal
chambers, the content and surfaces of the chambers specific for at least
two types of samples, wherein the samples are chosen from the group
consisting of coagulation, hematology, immunochemistry, and clinical
chemistry; andaliquoting from at least two of the chambers at least a
portion of biological fluid temporarily residing in each chamber to at
least one unique aliquot tube per chamber.

5. The method of claim 4, wherein an indicium exists on the cartridge,
wherein the indicium is interrogated by a scanning element prior to
aliquoting.

6. The method of claim 5, wherein the indicium is a 1 dimensional or 2
dimensional bar code.

Description:

FIELD OF THE INVENTION

[0001]This invention relates to body fluid collection devices,
particularly for the collection of whole blood. More particularly, the
invention relates to fluid collection devices wherein multiple,
individual samples of fluid from the same source can be withdrawn
simultaneously.

[0003]Improvements to the embodiments disclosed in U.S. Pat. No. 5,743,861
to Columbus et al. have been recognized. Provided is a blood collection
device comprising a cartridge with a septum for interfacing with a fluid
collection valve or port (i.e., blood collection needle, catheter port,
blood collection set), a manifold in fluid communication with the
piercing septum, a plurality of collection reservoirs in fluid
communication with the manifold, each collection reservoir having
additives and/or surface modifications and treatments that provide
appropriate environmental conditions within the reservoir to achieve
blood or sample stability for the test it is intended to be a part of. In
certain embodiments, each reservoir would be designed such that a vacuum
driving force would not be required to move the sample from the patient
into the reservoirs.

[0004]Also disclosed is an analyzer that receives a cartridge and
subsequently extracts from the cartridge from a plurality of collection
reservoirs the aliquoted sample into individual sample vessels specific
to the type of test (coagulation, hematology, clinical and/or
immunochemistry).

[0005]Additional disclosure is directed to a blood analyzer wherein the
analyzer receives a cartridge and within the analyzer is capable of
performing coagulation, hematology, and clinical and/or immunochemistry
analyses, especially from a single collection cartridge.

[0006]Further, a method for aliquoting biological fluids comprises the
steps of: receiving a cartridge, the cartridge comprising multiple
internal chambers, the content and surfaces of the chambers specific for
at least two types of samples, wherein the samples are chosen from the
group consisting of coagulation, hematology, immunochemistry, and
clinical chemistry; and aliquoting from at least two of the chambers at
least a portion of biological fluid temporarily residing in each chamber
to at least one unique aliquot tube per chamber. An indicium may exist on
the cartridge, wherein the indicium is interrogated by a scanning element
prior to aliquoting. For example, the indicium may be a 1 dimensional or
2 dimensional bar code.

DESCRIPTION OF THE FIGURES

[0007]FIG. 1A shows a perspective view of a holder that relates to an
embodiment of the invention.

[0008]FIG. 1B shows a perspective view of a cartridge that relates to an
embodiment of the invention.

[0009]FIG. 1C shows a plan view of the cartridge depicted in FIG. 1B.

[0010]FIG. 1D shows a perspective view of an instrument that relates to an
embodiment of the invention.

[0011]FIG. 2A shows a perspective view of a holder that relates to an
embodiment of the invention.

[0012]FIG. 2B shows a perspective view of a cartridge that relates to an
embodiment of the invention.

[0014]FIG. 3A shows a perspective view of an instrument that relates to an
embodiment of the invention.

[0015]FIG. 3B shows a plan view of the cartridge depicted in FIG. 3A.

[0016]FIG. 3C shows a side view of a transport vessel that relates to the
present invention.

[0017]FIG. 3D shows a side view of test specific vessels that relate to
the present invention.

[0018]FIG. 4 shows a flow chart that relates to the present invention.

[0019]FIG. 5 shows a flow chart that relates to the present invention.

DETAILED DESCRIPTION

[0020]Described herein is a blood collection device for collecting and
introducing in parallel, patient venous blood into a sealed
multi-chambered cartridge 20, while preventing cross-contamination
between the chambers. Because each chamber is isolated from the others,
each chamber may contain chemical reagents or additives, which, in
conventional evacuated tubes, would require separate tubes. The blood
collection device of the invention allows simultaneous filing of each
chamber by way of a distributor, which can be selectively placed into
essentially simultaneous fluid communication with a plurality of the
evacuated chambers. The blood is then able to pass from the source
through the manifold and into the chambers.

[0021]The device of the invention is easy to use as it is compact and has
a generally rectangular cross-sectional longitudinal shape and functions
in a manner that closely resembles current blood collection technology
with flexibility in fluid driving force. In particular, the blood
collection device 20 is designed for use with a needle holder 10 and thus
may be used when necessary or desired in conjunction with aliquot tubes
or containers 240 for use with multiple test-specific analyzers (for
instance, a coagulation aliquot tube or container 240a comprising citrate
intended for coagulation testing; a hematology aliquot tube or container
240b comprising EDTA intended for hematology testing; or a clinical
chemistry aliquot tube or container 240c comprising clot activator or
enhancing surface to effect the intrinsic, extrinsic, or both intrinsic
and extrinsic clotting cascades). By collecting and containing all of the
desired blood samples in a single multi-chambered vessel, the number of
disposables can be minimized and because multiple tubes and secondary
containers may be eliminated, positive patient identification can be
improved without requiring multiple container labeling for one patient
sample. Furthermore, as discussed in more detail below, embodiments of
the present invention employ features which may make it straightforward
and inexpensive to manufacture despite the device's sophisticated
capabilities.

[0022]The collection device 20 may be manufactured as components and
assembled just prior to the taking of the patient sample or can be
pre-assembled and ready-to-use. The device can be manufactured by
utilizing any number of methods known in the art, however, the preferred
method is one in which most parts are injection molded of a suitable
plastic. Such plastics make the device light, unbreakable, and
manufacturable at a modest cost. Furthermore, the collection device is
preferably made of a biocompatible, U.S. Food and Drug Administration
(FDA) approved plastic and metal components where desired that are
compatible with the blood samples, chemical treatments, and analytical
tests to be performed.

[0023]The overall internal cavities of each collection chamber in the
blood collection device as well as the distributor aperture may be
sealed, for example, with septums or self-healing seals. For instance, in
a collection device 20 with multiple chambers 42, 44, and 46, septums 26,
28, and 30 respectively enable engagement between an aliquoting or
extracting member inserted into each chamber respectively through a seal.
Such seals and septums are known in the art and allow penetration by a
point, i.e., needle, such that upon withdrawal of the point, the seal
substantially reseals to preclude fluid passage. Suitable materials for
the seals are well known in the art and should be selected based on the
intended use for the device such as biocompatibility, chemically inert,
and compatible with any chemical reagents or treatments contained
therein, be FDA approved, and suitable for use in automated instruments.
Each aperture may be individually sealed after evacuation.

[0024]In operation, the blood collection device 20 may be used with a
needle holder assembly 10 similar to that used for a conventional,
evacuated blood collection tube (such as VACUTAINER® marketed by
Becton Dickinson and Company). The cartridge has a distal end 22 and a
proximal end 24. After the needle is inserted into a vein, the penetrable
septum 32 on the cartridge's distal end 22 is penetrated by the cannula
14 exposing the flow manifold in the cartridge to the blood source. A
driving force in the chambers and manifold draws the blood through the
cannula 14, the plenum/manifold, and into the respective chambers (42,
44, and 46) or reservoirs assisted by the venous pressure provided by the
patient. When blood flow has ceased, the multi-chambered body/adapter
unit may be removed from the needle holder assembly 10 as is the
procedure with standard, evacuated collection tubes. The multi-chambered
body may then be drawn away or removed completely from the adapter,
allowing the self-healing septum 32 to reseal, thereby providing a
plurality of chambers or reservoirs sealed with and containing blood.

[0025]As shown in FIGS. 1B, 1C, 2B, and 2C, the proximal end 22 of the
cartridge 20 has at least one extraction port (26, 28, or 30) for each
corresponding reservoir (42, 44, and 46 shown as dotted lines in FIG.
1C). The extraction ports may be employed to extract each sample of blood
retained within the reservoir into an aliquoting instrument 200 shown in
FIGS. 3A and 3B, wherein the instrument extracts the individual samples
and transfers the samples into discreet, non-integral collection devices
240. This is shown in FIGS. 3A-3D. After the samples have been extracted
from the cartridge 20 and segregated into different collection transport
vessels 240, the vessels 240 may then be employed for analysis at a
latter time in test-specific instruments.

[0026]Alternatively, the extraction port (26, 28, and 30) may be employed
to extract each sample of blood retained within the reservoir into a
multiple test instrument, wherein the instrument extracts the sample as
needed and performs the appropriate analysis by whatever sample is
extracted. In this embodiment shown in FIGS. 1A-1D, the instrument would
likely need to identify and distinguish where within the cartridge 20 the
sample for a certain type of test is located. In one embodiment, the
instrument would be able to position the cartridge into the instrument
and the geometry of the cartridge would enable only one orientation such
that the instrument consistently recognizes which extraction port is
needed to be accessed for specifically extracting the desired sample. In
another embodiment, the instrument may scan an identifier 34 on the
cartridge 20 (see FIG. 1B for identifier) to determine what extraction
port is needed to be accessed. The above two embodiments are represented
in FIG. 1B as well as 3A-3D.

[0027]In an embodiment of the invention, the internal cavity of the
cartridge may employ a vacuum or partial pressure less than that of
atmospheric pressure. The driving force of this vacuum assists in the
delivery of blood from a patient's blood stream upon established fluid
connection between the patient's blood and the cavity. To maintain
vacuum, the sidewall and septums enclosing the cavity must be resistant
to vacuum loss over a reasonable period of time, such as a year. In an
embodiment of the invention, a foil seal covers the septum between the
internal cavity of the cartridge such that once the foil seal is broken,
the pressure between the cavity and the patient's blood attempt to
equalize, thereby drawing the blood sample into the cavity and individual
reservoirs.

[0028]As shown in FIG. 1, the assembled cartridge 20 accesses a needle 14
or port that is in fluid communication with a patient's vein. The distal
end 22 of the cartridge 20 is shaped to allow for the cartridge to fit
inside the proximal end of a holder 10. The holder 10 and cartridge 20
must be shaped in a manner to enable the cartridge to fill upon an
establishment of connection. For instance, as shown in FIG. 1A holder 10
has conforming geometry such as a slot that conforms to the shape of the
distal end 22 of cartridge 20. The driving force may be venous pressure,
a partial vacuum inside the cartridge, capillary action, gravity, or
other similar driving force such that the appropriate amount of fluid
enters the reservoirs for appropriate filling. The proximal end 22 of the
cartridge 20 may comprise at least one extraction port (26, 28, or 30)
for each reservoir contained within the cartridge. For example a
cartridge with three reservoirs (i.e., hematology reservoir 42,
coagulation reservoir 44, and clinical chemistry reservoir 46) would have
three extraction ports 26, 28, and 30 respectively.

[0029]FIG. 4 provides a flow chart indicating the manner in which
embodiments of the present invention may operate. Fluid communication is
established between a patient's bodily fluids and a port of the cartridge
(step 410). The fluid is introduced into the cartridge (step 420). The
cartridge is interfaced with an analyzer (step 430). Finally, the
analyzer performs multiple tests from different types of samples
(hematology, coagulation, chemistry) within the same cartridge (step
440). For instance, the hematology sample within the cartridge may
comprise EDTA within the chamber. The coagulation sample within the
cartridge may comprise citrate. The chemistry portion of the cartridge
may include clot activation surfaces commonly known in the art to promote
the activation of either or both of the extrinsic or intrinsic clotting
cascade.

[0030]FIG. 5 provides a flow chart indicating the manner in which
embodiments of the present invention may operate. For instance, in step
510, fluid communication is established between the patient's bodily
fluids and a port. In step 520, the patient's fluids are introduced into
the cartridge through one end of the cartridge. In step 530, the
cartridge is interfaced with an analyzer (and/or aliquoter). Finally, in
step 540, a sample analysis chosen from the group of hematology, clinical
chemistry, immunochemistry, and coagulation is performed on the
cartridge.

[0031]The present invention has been described with reference to preferred
embodiments. One of skill in the art will readily appreciate that
changes, alterations or modifications can be made to these embodiments
without departing from the true scope and spirit of the invention.